Cleared Traditional

K852073 - VIAL SYRINGE PUMPS, SE200, SE200B & SE400 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852073 · Hospal Medical Corp. · General Hospital
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Jun 1985
Decision
25d
Days
Class 2
Risk

K852073 is an FDA 510(k) clearance for the VIAL SYRINGE PUMPS, SE200, SE200B & SE400. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hospal Medical Corp. (East Brunswick, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospal Medical Corp. devices

Submission Details

510(k) Number K852073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date June 07, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 128d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 847
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